Surveillance of Pancreatic Health After Diabetes Diagnosis
A Randomised Trial to Evaluate the cfDNA Pancreatic Cancer Test (Avantect) in the Early Detection of Pancreatic Cancer in Patients With Newly Diagnosed Diabetes Mellitus
University Hospital Southampton NHS Foundation Trust
15,000 participants
May 21, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this interventional study is to evaluate if the novel diagnostic blood test, called Avantect can early detect pancreatic cancer in patients diagnosed with type 2 diabetes within the last 6 months. Participants will: * attend 3 study visits over 12 months time * provide a blood sample at each study visit * complete an anxiety questionnaire at each visit.
Eligibility
Inclusion Criteria5
- years of age at the time of enrolment (within year of birth, not month of birth)
- Haemoglobin A1c (HbA1c) ≥ 48 or 6.5% and/or confirmed type II DM diagnosed within the last 180 days (+20 days flexibility allowance)
- Willing to provide up to 30 mL of blood for each study visit
- Willing and eligible to undergo MRI scan (or CT scan if MRI is contraindicated)
- Understands the study process and is willing to take part in the study and sign the informed consent form
Exclusion Criteria10
- Prior type I or type II DM diagnosis \> 6 months
- A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
- Under investigation for pancreatic cancer / pancreatic cyst
- Any known pancreatic surgery (not including ERCP), or other major surgery requiring anaesthesia within 3 months
- Any invasive solid or haematological cancer in the past 3 years, including cancer recurrence after treatment in the last 3 years
- Current chronic or acute oral or systemic steroid use within 3 months of initial HbA1c or diabetes diagnosis (estimate rather than accurate)
- Blood transfusion within 1 month
- Solid organ transplant recipient
- Currently pregnant
- Needing dialysis
Interventions
Avantect test
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT06803771